Cleared Traditional

K182611 - Qangio XA 3D (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K182611 · Medis Medical Imaging Systems BV · Radiology device
May 2019
Decision
251d
Days
Class 2
Risk

K182611 is an FDA 510(k) clearance for the Qangio XA 3D. This device is classified as a X-ray Angiographic Imaging Based Coronary Vascular Simulation Software Device (Class II - Special Controls, product code QHA).

Submitted by Medis Medical Imaging Systems BV (Leiden, NL). The FDA issued a Cleared decision on May 30, 2019, 251 days after receiving the submission on September 21, 2018.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1600. X-ray Angiographic Imaging Based Coronary Vascular Simulation Software Device Is A Prescription Device That Provides An Image Analysis Tool To Assess Blood Flow In The Coronary Vascular System Using X-ray Angiographic Imaging Data. X-ray Angiographic Imaging Based Coronary Vascular Simulation Software Device Solves Algorithms And Yields Simulation-based Metrics For Certain Cardiology Applications. X-ray Angiographic Imaging Based Coronary Vascular Simulation Software Device Cannot Be Used Alone For Clinical Decision Making And Clinical Management, And Is A Tool Intended To Generate Results For Use And Review By A Qualified Clinician..

Submission Details

510(k) Number K182611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2018
Decision Date May 30, 2019
Days to Decision 251 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
124d slower than avg
Panel avg: 127d · This submission: 251d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QHA X-ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1600
Definition X-ray Angiographic Imaging Based Coronary Vascular Simulation Software Device Is A Prescription Device That Provides An Image Analysis Tool To Assess Blood Flow In The Coronary Vascular System Using X-ray Angiographic Imaging Data. X-ray Angiographic Imaging Based Coronary Vascular Simulation Software Device Solves Algorithms And Yields Simulation-based Metrics For Certain Cardiology Applications. X-ray Angiographic Imaging Based Coronary Vascular Simulation Software Device Cannot Be Used Alone For Clinical Decision Making And Clinical Management, And Is A Tool Intended To Generate Results For Use And Review By A Qualified Clinician.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.